Intraocular Pressure Clinical Trial
Official title:
Effect of Different Fluid Volume on Ocular Parameters in Patients Undergoing Spine Surgery in Prone Position
NCT number | NCT03890510 |
Other study ID # | FOCUS |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2019 |
Est. completion date | September 7, 2020 |
Verified date | December 2020 |
Source | Huashan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this trial is to compare the effect of different fluid volume infusion on ocular parameters in patients undergoing spine surgery in prone position.
Status | Completed |
Enrollment | 97 |
Est. completion date | September 7, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Scheduled for elective spine surgery in prone position under general anesthesia - American Society of Anesthesiologists (ASA) physical status I or II - Have signed consent form Exclusion Criteria: - History of eye disease or eye surgery - Pregnancy or breast feeding - Known Allergy to latex or Ringer's lactate solution - Hyperlactacidemia,uncontrolled hypertension, diabetes mellitus, arrhythmia, cardiovascular disease,chronic pulmonary disease, swelling of any body part, abnormal of liver or renal function, anemia, etc. - Body mass index(BMI)>30 - Expected operation time >6 hours - Estimated Intraoperative hemorrhage >1000ml - Taking part in other clinical trials in the last 3 months or at present |
Country | Name | City | State |
---|---|---|---|
China | Huashan Hospital Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital |
China,
American Society of Anesthesiologists Task Force on Perioperative Visual Loss. Practice advisory for perioperative visual loss associated with spine surgery: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Visual Loss. Anesthesiology. 2012 Feb;116(2):274-85. doi: 10.1097/ALN.0b013e31823c104d. — View Citation
Blecha S, Harth M, Schlachetzki F, Zeman F, Blecha C, Flora P, Burger M, Denzinger S, Graf BM, Helbig H, Pawlik MT. Changes in intraocular pressure and optic nerve sheath diameter in patients undergoing robotic-assisted laparoscopic prostatectomy in steep 45° Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3. — View Citation
Cheng MA, Todorov A, Tempelhoff R, McHugh T, Crowder CM, Lauryssen C. The effect of prone positioning on intraocular pressure in anesthetized patients. Anesthesiology. 2001 Dec;95(6):1351-5. — View Citation
Farag E, Sessler DI, Kovaci B, Wang L, Mascha EJ, Bell G, Kalfas I, Rockwood E, Kurz A. Effects of crystalloid versus colloid and the a-2 agonist brimonidine versus placebo on intraocular pressure during prone spine surgery: a factorial randomized trial. — View Citation
Grant GP, Szirth BC, Bennett HL, Huang SS, Thaker RS, Heary RF, Turbin RE. Effects of prone and reverse trendelenburg positioning on ocular parameters. Anesthesiology. 2010 Jan;112(1):57-65. doi: 10.1097/ALN.0b013e3181c294e1. — View Citation
Lee LA, Roth S, Posner KL, Cheney FW, Caplan RA, Newman NJ, Domino KB. The American Society of Anesthesiologists Postoperative Visual Loss Registry: analysis of 93 spine surgery cases with postoperative visual loss. Anesthesiology. 2006 Oct;105(4):652-9; quiz 867-8. — View Citation
Lee LA. Perioperative visual loss and anesthetic management. Curr Opin Anaesthesiol. 2013 Jun;26(3):375-81. doi: 10.1097/ACO.0b013e328360dcd9. Review. — View Citation
Li A, Swinney C, Veeravagu A, Bhatti I, Ratliff J. Postoperative Visual Loss Following Lumbar Spine Surgery: A Review of Risk Factors by Diagnosis. World Neurosurg. 2015 Dec;84(6):2010-21. doi: 10.1016/j.wneu.2015.08.030. Epub 2015 Sep 1. Review. — View Citation
Nandyala SV, Marquez-Lara A, Fineberg SJ, Singh R, Singh K. Incidence and risk factors for perioperative visual loss after spinal fusion. Spine J. 2014 Sep 1;14(9):1866-72. doi: 10.1016/j.spinee.2013.10.026. Epub 2013 Nov 8. — View Citation
Roth S. Perioperative visual loss: what do we know, what can we do? Br J Anaesth. 2009 Dec;103 Suppl 1:i31-40. doi: 10.1093/bja/aep295. Review. — View Citation
Uribe AA, Baig MN, Puente EG, Viloria A, Mendel E, Bergese SD. Current intraoperative devices to reduce visual loss after spine surgery. Neurosurg Focus. 2012 Aug;33(2):E14. doi: 10.3171/2009.8.FOCUS09151. Review. — View Citation
Warner MA. Postoperative visual loss: experts, data, and practice. Anesthesiology. 2006 Oct;105(4):641-2. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change of intraocular pressure | Intraocular pressure will be measured with a TONO-PEN AVIA handheld tonometer. | 10min after anesthesia induction(supine1), 10min after prone position(prone1), 1 hour after the prone position(prone2), 2 hour after the prone position(prone3),at the end of the surgery(prone4), and 10min after return to the supine position(supine2). | |
Secondary | The change of the optic sheath diameter | The optic sheath diameter will be measured with a Sonocite Portable Ultrasonic System EDGE. | 10min after anesthesia induction(supine1), 10min after prone position(prone1), 1 hour after the prone position(prone2), 2 hour after the prone position(prone3),at the end of the surgery(prone4), and 10min after return to the supine position(supine2). |
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